Regulatory Affairs & Quality Manager

Job Description

We are currently working with a leading multinational developer and manufacture of medical technologies which cover a variety of different clinical areas from Surgical to Vascular and who can boast being a market leader in their fields.

Due to their continued development they are currently looking to recruit an experienced Quality and Regulatory Manager to join their team and take charge on the UK and Irish markets.

The role will be responsible but not limited to:

  • Managing all post market regulatory and quality compliance activities for products placed on the market in UK & Ireland;
  • Complaints handling and Regulatory Authority reporting for medical device in accordance with local and European regulatory requirements;
  • Product notifications to the national Regulatory Authorities in Support of business plans and objectives;
  • Quality Management Systems Processes and procedures including information governance
  • Lead QMS project improvements within the UK & Ireland

To be considered for this position candidate should be degree educated and have at least 5 years experience working within a medical device, Pharma or pharmacy environments.  You should also have knowledge of CE marking and local competent authority requirements, good working knowledge of quality management systems requirement, especially ISO9001& 13485.

This is an excellent opportunity for a quality professional to develop their career within a well establish organisation who will need this individual to be dynamic, driven and willing to think outside the box and have the ability to lead and deliver change through a matrix organisation.

 
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